Data / Medical devices / China / Depuy Synthes (suzhou) Medical Devices Co., Ltd.
Depuy Synthes (suzhou) Medical Devices Co., Ltd.: FDA-registered device maker in SUZHOU Jiangsu, China, 70 510(k) clearances and 2 PMA approvals
Depuy Synthes (suzhou) Medical Devices Co., Ltd. is registered with the FDA (registration 3006356043) in SUZHOU Jiangsu, China. It lists 36 device types. The FDA files 70 510(k) clearances and 2 PMA approvals under its listings, the newest dated May 22, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3006356043
- Address
- No.293, Changyang Street Suzhou Industrial Park, SUZHOU Jiangsu, China, 215126
- Owner or operator
- DePuy Synthes, Inc. (1818910)
- Roles
- Manufacturer
- First device listed
- November 22, 1992
- Registered through
- 2027
- Brand names listed
- AML ( hip), ATTUNE Medial Stabilized Fixed Bearing Insert, ATTUNE REV FB INSERT IMPACTOR, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 3, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 4, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 5, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 6, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 7 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 22, 2026 | K252887 | DePuy ATTUNE Knee System | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 19, 2024 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional | MEH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 19, 2023 | K231526 | CORAIL Cemented Femoral Stem | KWY | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| July 22, 2022 | K220216 | C-Stem AMT LE Prosthesis | JDI | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 19, 2022 | K212683 | GLOBAL ICON Stemless Shoulder System | PKC | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| September 15, 2021 | K212710 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| August 25, 2021 | K211609 | ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert | JWH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| August 5, 2021 | K211657 | EMPHASYS Femoral Stems | LZO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 25, 2020 | K202098 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| October 21, 2020 | K202472 | ACTIS Duofix Hip Prosthesis | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| April 24, 2020 | K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System | NKB | Substantially Equivalent | Medos International Sàrl | accessdata.fda.gov |
| May 17, 2019 | K183077 | Delta Xtend Reverse Shoulder System | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| April 26, 2018 | K170339 | Summit Hip System | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 11, 2018 | K170748 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| June 15, 2017 | K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | JWH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| July 19, 2016 | K160907 | DePuy Actis DuoFix Hip Prosthesis | MEH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| July 1, 2016 | K160904 | Expedium Spine System, VIPER and VIPER 2 Systems | NKB | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| June 10, 2016 | K160700 | ATTUNE Revision Knee System | JWH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| September 25, 2015 | K150862 | DePuy Actis Duofox Hip Prosthesis | MEH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 1, 2014 | K142460 | EXPEDIUM Spine System/Synapse System | KWP | Substantially Equivalent | Johnson and Johnson | accessdata.fda.gov |
| April 3, 2014 | K133834 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | KWS | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| April 30, 2013 | K120599 | DEPUY M-SPEC 36MM FEMORAL HEADS | LPH | Substantially Equivalent | Depuy Orthopaedics | accessdata.fda.gov |
| June 14, 2012 | K111136 | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM | NKB | Unknown | Depuy Spine, Inc. | accessdata.fda.gov |
| June 11, 2012 | K120174 | DEPUT DELTA XTEND REVERSE SHOULDER | PHX | Substantially Equivalent | Depuy France | accessdata.fda.gov |
| August 30, 2011 | K111433 | DEPUY STTUNE (TM) PS KNEE SYSTEM | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 15, 2010 | K101996 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| December 10, 2010 | K101433 | DEPUY ATTUNE KNEE SYSTEM | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 18, 2008 | K082500 | DEPUY SIGMA CR-F FEMORAL COMPONENT | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 29, 2008 | K082239 | DEPUY C-STEM AMT | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 30, 2008 | K081620 | MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM | KWS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 22, 2004 | K042959 | DEPUY C-STEM AMT HIP PROSTHESIS | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 28, 2004 | K040544 | DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| March 31, 2004 | K033901 | MERLIN SPINE SYSTEM | NKB | Substantially Equivalent | Depuy Spine, Inc. | accessdata.fda.gov |
| February 23, 2004 | K040166 | DEPUY SIGMA XLK TIBIAL INSERTS | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 5, 2004 | K033272 | DEPUY SIGMA TIBIAL INSERTS | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 26, 2003 | K032151 | DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS | JWH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| February 5, 2003 | K030122 | DEPUY SUMMIT BASIC PRESS-FIT HIP STEM | LWJ | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 13, 2002 | K023453 | DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 17, 2001 | K013352 | SUMMIT CEMENTED HIP PROSTHESIS | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 1, 2000 | K003421 | DEPUY C-STEM SYSTEM | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 10, 2000 | K000575 | GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD | KWS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 12, 1999 | K992065 | GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD | KWS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 14, 1999 | K984541 | GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD | KWT | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 27, 1998 | K983014 | SUMMIT ACETABULAR SYSTEM | LPH | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| October 5, 1998 | K982918 | DEPUY C-STEM SYSTEM | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 29, 1998 | K980801 | J-FX BIPOLAR HEAD | KWY | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| April 14, 1998 | K980513 | ARTICUL/EZE FEMORAL HEADS | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 12, 1997 | K972596 | DEPUY DURALOC ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| July 17, 1997 | K971189 | P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) | JWH | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| November 12, 1996 | K963309 | APEX HOLE ELIMINATOR PS | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| September 17, 1996 | K961186 | DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| July 10, 1996 | K961685 | P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) | JWH | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| January 18, 1996 | K952830 | DARWIN KNEE SYSTEM (TC3) | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| September 18, 1995 | K940743 | UHMWPE COMPONENTS-CHANGE IN PACKAGING | KWY | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| August 18, 1995 | K952740 | DEPUY DURALOC 400 ACETABULAR CUP | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| May 15, 1995 | K950010 | DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| April 18, 1995 | K951301 | DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| December 21, 1994 | K943462 | DARWIN KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| October 3, 1990 | K903084 | MODULAR CATHCART FRACTURE SYSTEM | LZY | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| May 4, 1990 | K900832 | MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA. | JDI | Substantially Equivalent for Some Indications | Depuy, Inc. | accessdata.fda.gov |
| March 12, 1990 | K900891 | MODIFIED AML + ACETABULAR CUP PROSTHESIS | JDI | Substantially Equivalent for Some Indications | Depuy, Inc. | accessdata.fda.gov |
| March 29, 1989 | K884796 | P.F.C.(TM) MODULAR KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| October 20, 1988 | K882234 | JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| October 11, 1988 | K883460 | FOCUS TOTAL HIP SYSTEM | JDI | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| April 8, 1988 | K871867 | ELITE MODULAR HIP SYSTEM | JDI | Substantially Equivalent | Thackray USA | accessdata.fda.gov |
| September 18, 1985 | K851422 | S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP | JDI | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| November 15, 1984 | K843909 | TITANIUM HIP 1019 | JDI | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| July 19, 1983 | K830927 | KNEE PROSTHESIS-TIBIAL COMPONENT | JWH | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| October 8, 1981 | K812672 | SELF-CENTERING HIP | KWY | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| December 16, 1980 | K802627 | ORTRON 90* HIP PROSTHESIS | JDI | Substantially Equivalent | Cintor Orthopaedic Div. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 23, 2010 | P070026 | CERAMAX CERAMIC HIP SYSTEM | MRA | 121 | September 4, 2026 | accessdata.fda.gov |
| April 12, 1985 | P830055 | LCS(R) TOTAL KNEE SYSTEM | NJL | 355 | October 9, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Updated September 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.